GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound (GLAGOV)

• Regression (any reduction from baseline) in PAV [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
• Nominal change in total atheroma volume (TAV) from baseline to week 78 [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
• Regression (any reduction from baseline) in TAV [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]

• Percentage of subjects demonstrating regression (any reduction from baseline) in PAV [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
• Nominal change in normalized total atheroma volume (TAV) from baseline to 78 weeks [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
• Percentage of subjects demonstrating regression (any reduction from baseline) in TAV [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]

This study will evaluate whether low-density lipoprotein (LDL-C) lowering with Evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in subjects with coronary artery disease taking lipid lowering therapy.

• Biological: Evolocumab (AMG 145)
  Subjects randomized to the Evolocumab (AMG 145) arm will receive Evolocumab (AMG 145) subcutaneously every 4 weeks
• Other: Placebo
  Subjects randomized to the placebo arm will receive Placebo subcutaneously every 4 weeks

• Experimental: Evolocumab (AMG 145)
  Evolocumab (AMG 145)
  Intervention: Biological: Evolocumab (AMG 145)
• Placebo Comparator: Placebo
  Placebo
  Intervention: Other: Placebo

Inclusion Criteria:

• Clinical indication for coronary angiography
• Subjects already taking statin therapy, niacin or ezetimibe at screening must have been on a stable dose for at least 4 weeks prior to screening LDL-C. Subjects not taking lipid-regulating therapy must enter the study via a lipid stabilization period. Subjects who are intolerant to statins must meet statin intolerance entry criteria
• Fasting LDL-C ≥ 80 mg/dL (2.07 mmol/L) with or without additional risk factors, or, LDL-C ≥ 60 -<80 mg/dL (1.55-2.07 mmol/L) in the presence of one major or three minor risk factors

Subjects must meet the following criteria at the qualifying coronary catheterization procedure:

• Evidence of coronary heart disease (at least one lesion in a native coronary artery that has >20% reduction in lumen diameter) or prior PCI
• Left main coronary artery <50% reduction in lumen diameter by visual estimation
• Target Coronary Artery for IVUS must be accessible to the IVUS catheter, must not have a >50% reduction in lumen diameter within the target segment (and at least 40mm in length); cannot have undergone prior PCI or CABG and is not a candidate for intervention over the next 18 months. It may not be a bypass graft, bypassed vessel or culprit vessel for previous MI.

Exclusion Criteria:

• Coronary artery bypass graft surgery < 6 weeks prior to the qualifying IVUS
• NYHA III or IV heart failure, or last known left ventricular ejection fraction less than 30%
• Uncontrolled cardiac arrhythmia that is not controlled by medications in the 3 months prior to randomization
• Known hemorrhagic stroke
• Uncontrolled hypertension at randomization
• Fasting Triglycerides ≥ 400 mg/dL (4.5 mmol/L) at screening
• Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c > 9%) at screening.
• Moderate to severe renal dysfunction (eGFR < 30 ml/min/1.73m2) at screening.